Flawed Drug Due To Bleeding

When the U.S. Food and Drug Administration released the result of a Mini-Sentinel assessment of Pradaxa, the new-age anti-clotting agent that serves as an alternative to the 60-year-old standby drug warfarin, the regulator noted that Pradaxa bleeding rates do not appear to be any higher than those of warfarin. The assessment, on the surface, may have served as an attempt to vindicate the FDA in the face of criticism over the approval of Pradaxa (dabigatran etexilate mesylate), which is far easier to monitor than the older warfarin. However, as noted recently in the New York Times, the report did not reference the serious attribute of dabigatran Pradaxa that once bleeding starts, it’s almost impossible to stop. The problem with Pradaxa is not shared by warfarin and that’s because doctors have means available to stop uncontrolled bleeding in warfarin patients. Such an antidote does not exist with Pradaxa — at least not yet. It was reported that Pradaxa has contributed to the bleeding deaths of at least eight patients at Memorial Hermann-Texas Medical Center in Houston.

The New York Times reported that no fewer than 542 deaths have been linked to Pradaxa – either due to bleeding or Pradaxa heart attack – in 2011 alone. The Institute for Safe Medication Practices notes that Pradaxa was also linked to more reports of injury or death than any of the more than 800 drugs the not-for-profit agency regularly monitors. Pradaxa has only been on the market since October 2010 and was quickly embraced by doctors for the ease of monitoring, with fewer dietary restrictions than Coumadin (warfarin).

In reference to Pradaxa side effects, manufacturer Boehringer Ingelheim stands behind Pradaxa as safe. The FDA is correct in that bleeding is also possible with warfarin. However, with the latter, bleeding can be stopped by administering vitamin K or other substances. There is no such antidote for dabigatran Pradaxa, but the FDA approved it anyway. That’s difficult to comprehend knowing the definite safety risks involved.